Identity
- Trade Name
- Albumin -BCG method TC-Matrix FDA UDI
- Generic Name
- Albumin IVD, reagent FDA UDI
- Device Name
- The Albumin -BCG method TC-Matrix is used for the quantitative determination of Albumin in serum or plasma on TC-Matrix analyzers FDA UDI
- Model / Reference
- A502-510TM FDA UDI
- Description
- The Albumin -BCG method TC-Matrix is used for the quantitative determination of Albumin in serum or plasma on TC-Matrix analyzers FDA UDI
Identifiers
- Catalog Number
- A502-510TM FDA UDI
- Primary DI / UDI-DI
- 10673486001020 FDA UDI
- 510(k) Number
- K875070 FDA UDI
- FDA Product Code
- CIX FDA UDI
- GMDN Term
- Albumin IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1035 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Albumin IVD, reagent
Albumin -BCG method TC-Matrix by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ALB — Randox Laboratories, Ltd. · Class II
Cleared under the same submission
K875070 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA UDI 738855a2-12bc-4e2c-8a12-ffd958692e2b 37 fields · synced May 30, 2026